NCT04080986

Brief Summary

Despite significant advances in resuscitation efforts, there are some patients who remain in refractory ventricular fibrillation (VF) during out-of-hospital cardiac arrest. Double sequential external defibrillation (DSED) and vector change defibrillation have been proposed as viable options for patients in refractory VF. This cluster randomized trial will compare (1) continued resuscitation using standard defibrillation; (2) resuscitation involving DSED; or (3) resuscitation involving vector change defibrillation, in patients presenting with refractory VF during out-of-hospital cardiac arrest. The results of this study will provide high level evidence of the impact of both DSED and vector change defibrillation on ROSC and patient survival after OHCA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
405

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

September 10, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

2.9 years

First QC Date

August 30, 2019

Last Update Submit

September 20, 2022

Conditions

Out-Of-Hospital Cardiac ArrestVentricular Fibrillation

Keywords

ResuscitationArrhythmia, CardiacHeart DiseasesHeart Arrest

Outcome Measures

Primary Outcomes (1)

  • Survival to Hospital Discharge

    Binary outcome of whether the patient was discharged alive from hospital or died prior to discharge.

    Through study completion of three years

Secondary Outcomes (5)

  • Neurologic outcome

    Throughout study completion of three years

  • Return of Spontaneous Circulation

    1 Day

  • VF termination after first interventional shock

    1 Day

  • VF Termination after all interventional shocks

    1 Day

  • Number of defibrillation attempts to achieve Return of spontaneous circulation

    1 Day

Study Arms (3)

Standard Arm

NO INTERVENTION

All defibrillation attempts will occur using the standard defibrillation method, i.e. defibrillation pads will be placed in the anterior-anterior configuration. The patient may also be administered antiarrythmic agents and epinephrine, as per current provincial standard.

Double Sequential Defibrillation

ACTIVE COMPARATOR

The first three shocks will occur with defibrillation pads placed in the anterior-anterior position. For all further shocks, a second set of defibrillation pads (via a second on scene EMS or fire defibrillator) will be applied in the anterior-posterior position, and defibrillation will be carried out by sequential defibrillation shocks provided by the two defibrillators (i.e. with a short delay between the two defibrillators). The patient may also be administered antiarrythmic agents and epinephrine, as per current provincial standard.

Procedure: Double Sequential Defibrillation

Vector Change Defibrillation

ACTIVE COMPARATOR

The first three shocks will occur with defibrillation pads placed in the anterior-anterior position. All further shocks will occur with the pads placed in the anterior-posterior position. The patient may also be administered antiarrythmic agents and epinephrine, as per current provincial standard.

Procedure: Vector Change Defibrillation

Interventions

Double Sequential DefibrillationPROCEDURE

Defibrillation using pad placement in anterior-posterior position

Double Sequential Defibrillation
Vector Change DefibrillationPROCEDURE

Defibrillation using two defibrillators, one with pad placement in anterior-posterior position and the other with pad placement in anterior-anterior position delivering two rapid sequential shocks.

Vector Change Defibrillation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years of age
  • Non-traumatic cardiac arrest of presumed cardiac etiology
  • Presenting rhythm of ventricular fibrillation or pulseless ventricular tachycardia
  • No ROSC or non-shockable rhythm after three consecutive shocks by EMS or fire department.

You may not qualify if:

  • Traumatic cardiac arrest
  • Patients with pre-existing do not resuscitate orders
  • Patients without VF or pulseless VT as presenting rhythm
  • Patients without three consecutive shocks delivered
  • Patients initially treated by non-participating fire or EMS agencies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Peel Regional Paramedic Service

Brampton, Ontario, Canada

Location

Middlesex-London Paramedic Service

London, Ontario, Canada

Location

Halton Region Paramedic Services

Oakville, Ontario, Canada

Location

Ottawa Paramedic Service

Ottawa, Ontario, Canada

Location

County of Simcoe Paramedic Services

Simcoe, Ontario, Canada

Location

Toronto Paramedic Services

Toronto, Ontario, Canada

Location

Related Publications (4)

  • Drennan IR, Dorian P, McLeod S, Pinto R, Scales DC, Turner L, Feldman M, Verbeek PR, Morrison LJ, Cheskes S. DOuble SEquential External Defibrillation for Refractory Ventricular Fibrillation (DOSE VF): study protocol for a randomized controlled trial. Trials. 2020 Nov 26;21(1):977. doi: 10.1186/s13063-020-04904-z.

    PMID: 33243277BACKGROUND

  • Cheskes S, Dorian P, Feldman M, McLeod S, Scales DC, Pinto R, Turner L, Morrison LJ, Drennan IR, Verbeek PR. Double sequential external defibrillation for refractory ventricular fibrillation: The DOSE VF pilot randomized controlled trial. Resuscitation. 2020 May;150:178-184. doi: 10.1016/j.resuscitation.2020.02.010. Epub 2020 Feb 19.

    PMID: 32084567BACKGROUND

  • Cheskes S, McLeod SL. Double sequential external defibrillation for refractory ventricular fibrillation: the science, the controversies and the future. J Electrocardiol. 2025 Jul-Aug;91:154046. doi: 10.1016/j.jelectrocard.2025.154046. Epub 2025 Jun 4.

    PMID: 40483934DERIVED

  • Cheskes S, Verbeek PR, Drennan IR, McLeod SL, Turner L, Pinto R, Feldman M, Davis M, Vaillancourt C, Morrison LJ, Dorian P, Scales DC. Defibrillation Strategies for Refractory Ventricular Fibrillation. N Engl J Med. 2022 Nov 24;387(21):1947-1956. doi: 10.1056/NEJMoa2207304. Epub 2022 Nov 6.

    PMID: 36342151DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestVentricular FibrillationArrhythmias, CardiacHeart DiseasesHeart Arrest

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sheldon Cheskes, MD

    Sunnybrook Centre for Prehospital Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This is a cluster randomized trial, with cluster units defined by EMS agency. Each cluster will crossover at six month intervals for each EMS agency during the study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2019

First Posted

September 6, 2019

Study Start

September 10, 2019

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

September 22, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(6)